The revised GMP Directive

The long awaited revised GMP Directive taking into account the provisions of the Clinical Trials Directive (2001/20/EC) has been published. Directive 2003/94/EC came into force on 28 October and must be implemented by member states by 30 April 2004.

All the provisions of the original GMP Directive relating to medicinal products (91/356, which is repealed) are reproduced (with some editorial changes) and additional clauses take account of the provisions of the Clinical Trials Directive and the requirements of the revised annex 13 of the EU GMP Guide which relates specifically to the manufacture of investigational medicinal products. However, there continues to be some confusion over the status of this 'revision' of the Annex.

The relatively late publication of the revised GMP Directive and the still awaited GCP Directive, together with the confusions surrounding Annex 13, have hindered the implementation of the Clinical Trials Directive in member states. This continues to cause great concerns to industry, which is obviously anxious to know at the earliest opportunity the exact requirements with which it will have to comply by 1 May of next year.

While it has been argued that, in general terms, industry has known for some time the likely provisions, this is, in reality, no substitute for early publication of definitive legal requirements and guidance at both the EU and member state levels. ABPI and EFPIA continue to seek early clarification of outstanding points.

Let us hope that the Commission will bear in mind the lessons learned from the implementation of the Clinical Trials Directive and in framing future legislation will set realistic implementation dates to reflect properly the timescales required for orderly implementation.